Swedish Orphan Biovitrum AB (publ) Q3 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Brian Balchin - Jefferies - Analyst : Thank you. Two, If I may it's just on Beyfortus and competition. So just first your view on the extent to which that big 3Q Beyfortus beat was pulled forward. Anything you can share on the 3Q, 4Q dynamic particularly is related to the impact of 4Q consensus which I believe is around SEK1.4 billion, just how we should be thinking about that. And then secondly, on clesrovimab, just your thoughts on the competitiveness of those data, particularly on hospitalization, production differences on endpoints impacts on comparability and your view on potential just ballpark market share that you think that could take into the '25, '26 RSV season. Thank You

Question: Mattias Haggblom - Handelsbanken. - Analyst : Yeah, thanks so much for taking my questions. I have two please. The first long hemophilia and Germany, the 6% point share you gained in one quarter. So help me think about what that means for peak market share potential in Germany going forward since patients don't see a position more than perhaps once or twice a year? And linked to that. What that does it imply for other European markets? I believe Germanys already has been one of the of the strongest, there should be temporary expectations since it's accomplished in Germany or opposite. Should we see the initial uptake as encouraging also for other European markets? And then second on systemic pegcetacoplan. And this is curious to hear if there's any feedback from European regulators in terms of timelines, when you can submit those initial feedback, suggest you would have to wait for 12 months data or is there possibly a path to submit earlier? Given the magnitude of the effect on the primary end point?

Question: Mattias Haggblom - Handelsbanken. - Analyst : Can I squeeze in a follow up please? On hemophilia? Thanks so much for the clarification, but I think there is some investor concern around the impact out of our test on Elocto. So if you gain net 6% point share in Germany, I guess the factor eight franchise overall in that market must have grown by 20% year over year or so in the quarter.

Question: Mattias Haggblom - Handelsbanken. - Analyst : That's helpful. Thanks so much.

Question: Erik Hultgard - Carnegie - Analyst : Yes. Hi. Thanks for taking my questions. I have two. If I may first continue a bit on out work in Germany and the uptake, could you specify a bit the proportion of patients on out the work in the quarter that came from a lock, and competing products respectively? I think Gudio you mentioned that majority was from other products than they looked about. But if you can be a little bit more specific on the proportion there. And also, were there any stocking including in sales in the quarter for Out Box? And then I have a follow up on Vonjo. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 24, 2024 / 12:00PM, SOBIV.ST - Q3 2024 Swedish Orphan Biovitrum AB (publ) Earnings Call

Question: Erik Hultgard - Carnegie - Analyst : Okay. Very loud and clear. So then on Vonjo, I think you previously said that you expect to reach an inflection point in the uptake in the second half. And I was wondering if this is the case. It looks like you have some slight acceleration in the third quarter. But do you have any leading indicator data points such as prescription, new prescription data supporting that you're actually converting the a brand awareness data that you highlighted that this is actually converting to an acceleration in and also prescriptions?

Question: Erik Hultgard - Carnegie - Analyst : Sounds good. Yes, if I can sneak in the final short one on Vonjo. So could you say something about the proportion of patients starting on volumes that are above or below 15 in platelet counts?

Question: Erik Hultgard - Carnegie - Analyst : Perfect Thank you so much.

Question: Gonzalo Artiach Castanon - Danske Bank - Analyst : Hi, good afternoon, Gonzalo from Danske Bank. One on Beyfortus and the potential competitor from Merck in case of, of this competitor receiving approval for next season, if you have any color, you could share on any potential pricing pressure that this could imply for before to if you could give us some color here would be great. And also, on Vonjo, another question, I mean, you mentioned that the slower integration of CTI in Sobi has been one of the reasons for for sales taking. Yeah, being slower than, than we initially expected. But also, Jara, as it was mentioned previously, has had like a good launch here. So I was thinking, how are you actually planning to convert this 70% market awareness that you just mentioned, into sales especially? Yeah, out of label given the fact that the Jara is doing quite well or they are establishing itself in the market. And also, if I heard correctly in the presentation, you mentioned that your long-term goals for Vonjo are are untouched is it including new indications that you are starting now or excluding this? Thank you very much.

Question: Gonzalo Artiach Castanon - Danske Bank - Analyst : Great. Thank you very much.

Question: Christopher Uhde - SEB - Analyst : Hi there. Thanks for taking my questions. So obviously really impressive start for Altuvoct. And coming off such a high Elocto to share base. It must be rewarding after years of analysts telling you, Russia's Hemlibra is going to eat your lunch. But I do want to get a little clarity around how to think about Elocto through the conversion process component of the launch given that, you start, you started talking about positive phasing impacts on already back in Q1 '23 that only started to unwind this quarter. And obviously, we know payers wanted to ensure market stability, but the unwind does not seem to be factored into consensus. Can you help us understand what proportion of Altuvoct sales so far? Were switches from Elocta and how much stocking unwind is left? Are we talking SEK500 million kroner left or could it be more or less? Second, you had what truly looks like a phenomenal clinical result with Aspaveli. So of course, the share rose 15%-20% on the back of the first Blockbuster Cell side forecast following the announcement which you today are clearly backing. I know you hate when I ask long questions. So I'm sorry about that. But with up to 20% of market cap in play from this, the potential is pretty important to understand the number of, you know -- and the number of addressable patients especially because you used to say that there were up to 8,000 ex- US. Your partner still says 8,000 ex-US while you now say 8,000 in Europe alone, your share is up. Since then, your partners is down. Your presentations, say the estimate is based on the literature when I emailed. So to ask how it arrived at 8,000 reply cited review from Nature Reviews, nephrology. Summarizing data from Europe. And the reply specifically stated the French data set may be a good anchor. We have anchored on the 14 per million in the bottom range. So that's the estimate is based on that large French study and extrapolating that it takes us to 7,000 diagnosed patients in Europe which is pretty close to that 8,000. But reading how the review publication calculated the 14 per million, they state point prevalence values were calculated as new cases per year divided by the size of the referral population. In other words, the population of France times the population average life expectancy. They explicitly state we assume there were no deaths from C3G. They also do not remove patients who went into kidney failure. But we have that kidney failure rate data for that study from the publication and if you redo the calculation and subtract patients going into kidney failure each year, you're left with only 2,000 patients. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 24, 2024 / 12:00PM, SOBIV.ST - Q3 2024 Swedish Orphan Biovitrum AB (publ) Earnings Call So you know, and of course more recent large registry based data sets from UK Spain Italy, all give similar results. Are you simply expecting to be able to treat all the patients after they have already gone into kidney failure? Or how much of your estimate relies on anecdotal evidence from KOLs and market research. Does Aspaveli need a total addressable market of at least 8,000 patients in Europe to become a blockbuster. Thank you very much for your patience and for the questions,

Question: Harry Gillis - Berenberg - Analyst : Hi. Thanks for taking the questions. Just a couple of short ones from me. Just back on to Aspaveli, just wondering what your latest base case is for your relative market share versus Novartis that you're including in this the guidance for Blockbuster opportunity? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 24, 2024 / 12:00PM, SOBIV.ST - Q3 2024 Swedish Orphan Biovitrum AB (publ) Earnings Call And then just thinking about the the patient pool that is there today, is there, are you seeing a bonus of sort of well identified patients that are sitting there waiting for new targeted therapies? Just so we can think about how quickly the sales might ramp and then a very quick one on the financials. Do you also expect a significant step up in OpEx in Q4 like last year or is that sort of unique to last year? Thank you.